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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)
Generic NameImplant, dermal, for aesthetic use
ApplicantGENZYME BIOSURGERY
55 CAMBRIDGE PARKWAY
CAMBRIDGE, MA 02142
PMA NumberP030032
Supplement NumberS008
Date Received04/15/2009
Decision Date02/24/2010
Withdrawal Date 02/10/2016
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LABELING UPDATE TO CAPTIQUE AS A FOLLOW-UP TO THE POST-APPROVAL STUDY.
Post-Approval StudyShow Report Schedule and Study Progress
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